FDA Announces Draft Guidance For Global Quality Data Standardization
January 21, 2026
January 21, 2026
WASHINGTON, Jan. 21 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration is seeking public input on a draft guidance intended to harmonize the way pharmaceutical quality data is organized and submitted worldwide.
The document, titled "M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality," was developed alongside the International Council for Harmonisation of Technical Requirements for Pharm . . .
The document, titled "M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality," was developed alongside the International Council for Harmonisation of Technical Requirements for Pharm . . .